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2 Learning objectives Understand the current usage of stem cells from cord blood To be able to name three ways of over coming challenges with using cord blood Understand the current thinking on the mechanism of action for regenerative medicine 2

3 History of Cord Blood Transplantation and Banking -70s and -80s The early years -90s Establishing a new treatment Sibling to un-related -00 Expanding options Pediatric to adult -10 Regenerative medicine -72: 1st recorded use of CB -89: 1 st successful CB transplant -93: NYBC CBB established Mid-90s: publications of related and unrelated transplantations in children -98: Outcomes of 562 recipients Early -00: publications of engraftment in adult recipients -05: Usage of Double CB units for adults -08: 86 CB transplants in Canada -10: Accepted option for both children and adults -10: Regenerative medicine -11: Diabetes study -11: Case study on CP

4 Current status Transplantation: Cord blood is now a source of stem cells routinely used. Almost all studies published or presented are reinforcements of previous findings. Better outcomes with higher number of cells. Despite increase in Double transplants this is still the message Regenerative medicine: Watchful waiting. Many studies are done in China and Korea Cell dose (and what type of cell is needed) is unknown

5 Why chose Cord Blood Stem Cells? (Transplantation for hematological diseases) Timing Time between search and use Adult Stem Cells Generally 3 months Up to 10 months Cord blood Stem Cells 1 day 2 weeks Units stored and ready for use No Yes For patients that: - do not have a matched family donor - cannot wait 3 months for a search 5

11 Cord blood challenges Increase the number of CD34+ cells Ex vivo expansion Going on for years aim to shorten time to engraftment not yet quite there Notch-ligand based expansion Double unit transplants For adults very encouraging results Only one unit engrafts Combination of Expansion and double unit transplant Preliminary results encouraging: from 26 to 14.5 days to engraftment (n=11) Very expensive!! Collect more cells Rinse the placenta

19 Probability of transplant-related mortality (TRM) for patients 10 years of age or older. van Rood J J et al. PNAS 2009;106: by National Academy of Sciences

20 Time to absolute neutrophil count (ANC) 500/mm3 (at day 77) for the subset of patients transplanted with a CB unit with TNC per kilogram of body weight of < van Rood J J et al. PNAS 2009;106: by National Academy of Sciences

21 Time to relapse for patients with myelogenous malignancies. van Rood J J et al. PNAS 2009;106: by National Academy of Sciences

24 Cord blood transplantation for HIV?? Case report: A patient with HIV developed leukemia and required a stem cell transplantation At follow up it was discovered that the viral load was decreasing. Entry of HIV into cells requires CCR5-delta32 receptors on the lymphocytes Transplantation of CCR5-delta32 negative cells by chance led to decrease in viral load (39 months) 1% of Caucasians negative, mostly Scandinavians and Finns. Cord blood desirable as only 4/6 match is usually required. Should Cord Blood Banks test for CCR5? Ref: Hutter G. NEJM

25 Regenerative medicine: How does it work? In vitro, cord blood stem cells can become almost any cell! Do the transplanted cells migrate to the injured site and become the cell needed? Neurons Beta-cells Myocardiocytes Or??? 25

26 Regenerative medicine: How does it work? Current theory of mechanism: Protection from inflammation Allows re-generation of the body s own tissues, nerves Protection In vivo: most of the effects seen are due to immuno-modulation and anti-inflammatory response In some studies they infuse all the cells from the cord blood. So do we need a combination of cells or a specific cell?? CB contains: Haematopoietic stem cells Mesenchymal cells Very small-embryonic-like stem cells Unrestricted somatic stem cells Endothelial precursor cells.. 26

27 Regenerative medicine: Which cell is really the effector cell?? Mesenchymal stromal cells one of the candidates Can be found in almost any tissue Non-immunogenic (?) In vitro: can differentiate into almost any cell type What is the effect in vivo? 1 st clinical trial published 1999 (Horwitz et al. Nat Med 1999;5:309) Cells from Bone Marrow Children with Osteogenesis Imperfecta Very good clinical results but they could never find any donor cells 26 clinical trials with mesenchymal cells from Cord Blood registered w NIH. Are mesenchymal cells from cord blood different?? In most of these trials the cells need to be expanded Will that change the cell properties? 27

28 Regenerative medicine: Does it really work? Diabetes Type I Autologous cord blood infused within the first year after diagnosis. Preliminary finding: Decreased need of insulin after 6 months 1 year follow up of 15 patients Use of autologous cord blood is safe. Insulin requirements were no different compared with historical control group. Conclusion: if there was an effect, it did not last Open questions: Prolonged honey-moon. Protective mechanism?? The whole unit of cord blood was given. Cell dose? Maybe many small doses? Which cell? Haller et al, Exp Hematol 2008, Haller, Diabetes Care

29 Regenerative medicine: Does it really work? Ischemic brain injury, CP CB cells migrate to the site of injury Some differentiation Bystander effect Protects the brain from further injury by supressing the immune response Helps the brain heal itself 29

30 Regenerative medicine: Does it really work? CP Dr Kurtzberg at DUKE: May patients enrolled, 14 have been followed up 8 have shown functional improvement Blinded study started. N=120 Estimated completion: 2012 Other NIH funded study is also on-going University of Georgia, n=40 Estimated completion:

32 Family and Public Cord Blood Banking A good quality sample is a good quality sample where ever it is stored

33 Family and Public Banking Different models of Cord Blood Banking Family banking Public Banking Sample belongs to the family Directed or autologous use Most samples stored For future use Traditional use New areas of use - regenerative medicine Storage for a fee Sample belongs to the Bank To be used by anyone in need Only the best samples kept - expensive to store samples No cost to the donor 33

34 Cord Blood Options Three choices Do nothing Donate to a Public Bank Save Discarded as Medical Waste Research 80-85% Medical Use 15-20% Store for Family Use 34

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